Berlin Heart Enrolls First Patients in Clinical Study to Investigate Innovative Mobilization Option for Children Waiting for a Heart Transplantation

Berlin Heart is pleased to announce that the first patients are enrolled in the "E-MOTION" study: “The use of the EXCOR® Active driving unit for MObilizaTION of pediatric patients with Ventricular Assist Device support”.

Berlin Heart Clinical Research
(PresseBox) ( Berlin, )
This observational, international, multi-center study investigates the improved mobility, patient outcome and the impact of the mobile driving concept EXCOR® Active on quality of life, compared to the stationary driving unit IKUS.

EXCOR® Active is the innovative new driving unit that gives children, waiting for a donor heart more freedom to move, play and learn during their time on the EXCOR® Ventricular Assist Device.

“Within the prospective, clinical “E-Motion” study, we will observe twenty pediatric patients supported by the EXCOR® VAD,” outlines PD Dr. Dr. Thomas Schöndorf, Manager Clinical Research at Berlin Heart. “All these children suffer from advanced heart failure and are waiting for a heart transplantation. We plan to conduct the trial at ten study centers in five countries.”

As soon as the patient is able to get mobilized after implantation of the EXCOR® VAD, the patient can be included into the study. Every patient is observed for a 52-day time frame. During the first week, information is collected, while the pediatric patients are still connected to the stationary driving unit IKUS. On the seventh day the children get switched to the mobile driving unit EXCOR® Active and will be observed for another 45 days.

Patients or their parents will keep a mobility diary to gain information on how the EXCOR® Active supports the mobilization of the children. The impact on the lives of the patients and their families will be assessed with Quality of Life questionnaires.

The first three study patients are treated at the German Heart Institute in Berlin, Germany. Dr. med. Oliver Miera, Pediatric Cardiologist and Coordinating Investigator of the “E-Motion” study describes the intention: “The “E-Motion” study will provide valuable information of how we can offer children with end-stage heart failure more mobility and autonomy in their daily lives in the hospital environment.”

Clinical Research helps Berlin Heart to pursue a very clear vision: “With our life-saving therapies, we want to improve the quality of life of children with heart failure,” explains Dr. med. Ares K. Menon, Managing Director of Berlin Heart. “Conducting this study is another example of how Berlin Heart gives patients, parents and clinical partners a voice to target patient-centered innovations.”

For more information about the “E-Motion”- study, please visit:
https://clinicaltrials.gov/ct2/show/NCT04634708

For more information abot EXCOR® Active: https://www.berlinheart.de/en/medical-professionals/excorr-active/

Disclaimer: The access to some or all shown products may be restricted by country-specific regulatory approvals. The use of EXCOR® VAD for adults, RVAD-support, EXCOR® venous cannulas with grafts, Excor mobile and EXCOR® Active is not FDA-approved and not available for commercial use in the US.
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